Senior Scientist I Analytical Development

Role: Senior Scientist I in Analytical Development supporting small molecule CMC activities from preclinical to late-stage clinical development. Responsibilities: develop, validate, and transfer analytical methods (UPLC/HPLC, LC-MS, KF, dissolution) for starting materials, intermediates, drug substances, and products; review and trend analytical data; investigate non-conformance events; collaborate with CMC, QA, and CMOs/CTLs on documentation and regulatory submissions; author technical reports for IND, IMPD, and NDA filings. Requirements: BS/MS in chemistry or pharmaceutical sciences; 5+ years in analytical development, with expertise in techniques for small molecules and solid oral formulations; experience working with CMOs/CTLs; knowledge of ICH, cGMP, and regulatory standards. HighValue: small molecule drugs, early to late-stage development, analytical method validation, regulatory documentation, cGMP compliance. WorkSetup: onsite in South San Francisco; not remote.